Ipsen Reports Prelim Results Of Phase II Proof-of-Concept Trial With Tasquinimod

(RTTNews) - French pharmaceutical firm Ipsen S.A. (IPSEY) announced the presentation at the ESMO 2014 Congress (26-30 September in Madrid) of the preliminary results of the phase II proof-of-concept trial with tasquinimod in monotherapy, assessing the compound in four advanced tumor types.

Tasquinimod is a novel small molecule that targets the tumor microenvironment by binding to S100A9 and modulating regulatory myeloid cell functions, exerting immunomodulatory, anti-angiogenic and anti-metastatic properties

The study's main objective was to determine the clinical activity of tasquinimod in advanced hepatocellular (HCC), ovarian (OC), renal cell (RCC) and gastric (GC) carcinomas in patients who had progressed after standard anti-tumor therapies. Primary endpoint was the PFS rate at a predefined time for each cohort. Secondary objectives were PFS, response rate, OS, safety, pharmacokinetics and biomarkers.

The data failed to support further development of tasquinimod in monotherapy in heavily pretreated patients with advanced OC, RCC and GC. Pharmacokinetic and biomarkers analyses are ongoing. Preliminary results from the futility analysis reported sufficient clinical activity to complete the recruitment of the HCC cohort for which results are expected in 2015.

The safety profile was consistent with the known safety profile of tasquinimod in prior studies.

The "Umbrella" trial is a Phase II, multicenter, open-label, proof of concept study of tasquinimod in patients with advanced hepatocellular, ovarian, renal cell and gastric carcinomas.